Previously, the CPSC had proposed to exempt four plastics from phthalates testing. (See Regulatory Recap: August 2016). In support of the CPSC’s continued efforts to reduce third party testing burden, TERA has studied an additional eleven plastics to determine the presence of ten specified phthalates including the six Consumer Product Safety Improvement Act (CPSIA) regulated phthalates. The results of study may lead to further inclusion of plastics that are proposed to be exempted from CPSIA phthalate testing.

The overview of phthalates found in certain plastics is summarized below:

Present phthalate^

Plastic Types*

PMMA /PAN

EBR

EBC

EVA / EVOH

EPM / EPDM

Surlyn®

PC

GPS / MIPS / SHIPS / SBC

SR

SAN

SBS / SBR

DEHP

x

x

x

x

x

X

DBP

x

x1

x

x

x

x

x2

BBP

DINP

DIDP

DnOP

x

x

DIBP

x

x

x

x

DPENP

DHEXP

DCHP

x

x

Remarks:
1: Study found that the presence of DBP could be additives.
2: One study reported DBP at unspecified concentration in an unspecified toy.

The proposed bill bans the following food containers composed of BPA or which can release BPA into food:

Reusable food containers; and

Other food containers that are packed with food and are introduced or delivered for introduction into interstate commerce

Despite the proposed ban, the Food and Drug Administration (FDA) may grant waivers to a particular facility (defined in section 415 of the Federal Food, Drug, and Cosmetic Act) that manufactures, processes, packs holds or sells food product. However, the facility receiving such waivers must:

Demonstrate that it is not feasible to replace BPA in the certain type of container

Demonstrate that is it not feasible to use an alternative container without BPA

Have a plan and timeline for BPA removal

Display a prominent warning label on the product as below:“Bisphenol A (BPA) is a chemical that can leach into food and may harm prenatal development and the health of children and adults.”

Updates of ASTM Standards

Below is a summary of recently updated ASTM standards that may be of interest to our clients:

Standard Consumer Safety Specification for Non-Powder Guns
Establishes performance requirements and test methods intended to provide a reasonable degree of safety in the normal use of non-powder guns and projectiles.

-

ASTM F963-16

Standard Consumer Safety Specification for Toy Safety
Covers requirements and contains test methods for toys intended for use by children under 14 years of age. There are different age limits for various requirements in this specification. These limits reflect the nature of the hazards and expected mental or physical ability, or both, of a child to cope with the hazards.

16 CFR 1217

ASTM F1821-16

Standard Consumer Safety Specification for Toddler Beds
Covers requirements for the design and performance of toddler beds. It also contains requirements for labeling and instructional material.

On October 20, 2016, a new version (2016) of the ASTM F963 standard was published. The revision summary is listed below.

The ASTM F963 Toy Safety Standard

ASTM F963 has long been a key standard for toy safety testing. This standard addresses safety requirements for toys which are any object designed, manufactured or marketed as a plaything for children under 14 years of age (Excluding products listed in Appendix A).

According to the Consumer Product Safety Improvement Act (CPSIA), the updated standard will be enforced and become mandatory 180 days after ASTM has notified the Consumer Product Safety Commission (CPSC) of the update. However, the CPSC may reject the revision within 90 days.

The emergency regulation continues the adoption of a standard point-of-sale warning message for BPA for canned and bottled foods and beverages addressed in the previous amendment on California Code of Regulations (See Regulatory Recap: April 2016). The emergency regulation will expire on January 18, 2017.

In addition, OEHHA initiated a regular rulemaking process for BPA warnings (See Regulatory Recap: September 2016) but the rulemaking procedure has not been completed yet.

US State of California OEHHA Adds New Chemicals to Proposition 65 List

On October 21, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) added a new chemical to the Proposition 65 List. The new chemical is:1. Pentachlorophenol and by-products of its synthesis (complex mixture)

The added chemical meets the requirements for listing as known to the State of California to cause cancer for purposes of Proposition 65. The chemical details are provided below:

Chemical

Chemical Abstracts Service Number (CAS No.)

Types of Toxicity

Pentachlorophenol and by-products of its synthesis (complex mixture)

---

Cancer

California Proposition 65: Recent 60-Day Notices

In 1986, California voters approved an initiative titled California Proposition 65 to address their growing concerns about exposure to toxic chemicals. Since its origin, there have been many lawsuits that have resulted in reformulations of consumer products containing carcinogenic and reproductively harmful chemicals on the Cal Prop 65 list.

According to the Maine Toxic Chemicals in Children’s Products Law, manufacturers of children’s products are required to submit a report to DEP within 180 days after a priority chemical is newly identified if the product contains:

A priority chemical that is intentionally added to a component of children’s product at concentration above the Practical Quantification Limit (PQL); or

A priority chemical that is a contaminant present in a component of children’s product at a concentration above 100 ppm

In the draft rule, the following products are exempted from the reporting requirements:

Used products

Food and beverage packaging (except for product intended for use by children under 2 years old)

Updated the type of product information that is required to be reported:

Manufacturers will download an Excel template, which will be used to submit brand name and product model data.

If a product is offered for sale in different sizes or variations, the individual variations may need to be reported separately if the concentration of the chemical within the component is significantly different.

If a specific item that contains one of the 66 chemicals is sold in multiple toy sets (for example, one screw driver is sold as part of three different children’s toy construction sets) the disclosure would include the following:

The chemical used in the screw driver

The Product Model/Brand Name Excel form upload containing all product model and brand names that use the screw driver (as well as any other product models and brand names that use the chemical being reported)

The details about the screw driver (function of chemical, component, concentration of chemical, brick)

Added a guideline for manufacturers to report chemicals that are trade secret

Clarified that there is no additional waiver for small business or manufacturers

In Canada, when hazards are identified in consumer products, they will be recalled and published in the Recalls and Safety Alerts Database on the Health Canada website, which is updated daily. The Canada recalls from September 1 to October 30, 2016 are summarized below:

Shall not be manufactured, or placed on the market as substances on their own.

Shall not be used in the production of, or placed on the market in:

another substance, as a constituent

a mixture

an article, or any part thereof in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances.

Paragraphs 1 and 2 shall apply to:

Equipment used to manufacture semiconductors

Latex printing inks

Textiles for the protection of workers that must meet durable water repellency (DWR) performance standards

Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment

Plasma nano-coatings

Medical devices other than implantable medical devices within the scope of Directive 93/42/EEC

69

Methanol

67-56-1 (200-659-6)

Shall not be placed on the market to the general public in the following:

windscreen washing or defrosting fluids,

Denatured alcohol, in a concentration equal to or greater than 0.6 % by weight.

Turkey Ministry of Customs and Commerce Issues Toy Safety Regulations

On October 4, 2016, the Turkey Ministry of Customs and Commerce issued new Toy Safety Regulations (Number 29847). The regulations determine the procedures and principles for the importation of safe toys which are intended or designed for use in game play for children under 14 years of age.

The proposed amendments add new conditions for electronic and electrical products that may not be required to have markings directly on the product such as components, parts and raw materials. (Examples: display components, circuit boards, resistors, etc.) However, the marking is still required on the product instructions. The amendment was under comment period until November 13, 2016.

On July 21, 2016, Senate bill 838 was introduced in the 17th Congress of Senate of the Philippines. The bill proposes an amendment to the Republic Act No. 7394 Consumer Act of the Philippines including Chapter IV Labeling and Fair Packaging.

Key proposed amendments of the regulation related to labeling information on consumer products are summarized below:

Consumer products with product labels written in a foreign language shall have a corresponding English or Pilipino translation to allow better understanding of the product contents, features and uses

A new provision is added to ban suppliers from importing defective goods

The requirements for consumer products with specific claims are further strengthened by the ingredient list requirement. A specific claim can appear only when the ingredient’s quantities and properties as well as the material benefit that results from its inclusion in the product formulation have been technically substantiated.

In addition to changes in labeling requirements, the amendment also adds a new provision to ban suppliers from importing defective goods.

On September 9, 2016, the Korean Ministry of Trade, Industry and Energy (MOTIE) issued Notice 2016-481 through World Trade Organization (WTO) to propose revisions to the safety standards for children’s products covered by Article 22 of the Special Act on Safety of Children’s Products.